NCT00558675

A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy

A Phase I/II Study of Intentionally Mis-Matched, Allogeneic Th1 Memory Cells (AlloStim) Conjugated With CD3/CD28-coated Microbeads in Patients With Relapsed or Refractory Hematological Malignancy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mirror Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD).

Detailed description

AlloStim is combination biological drug and medical device formulation consisting of allogeneic immune cells that have been expanded and differentiated ex-vivo. These cells are conjugated to monoclonal antibody coated microparticles prior to infusion. The immune cells are living CD4+ memory Th1-like T-cells (T-Stim) that are differentiated from precursors purified from normal donor blood. AlloStim is a composition of T-Stim cells conjugated to paramagnetic epoxy covered microparticles (4.5micron) with covalently bound anti-CD3/anti-CD28 monoclonal antibodies (Dynabeads® ClinExVivo™ CD3/CD28) at a 2:1 bead:cell ratio. The T-Stim cells are intentionally mismatched to the recipient. The graft vs. tumor (GVT) effect that occurs after allogeneic bone marrow transplant (BMT) is a curative therapy for advanced hematological malignancy but the clinical application of GVT is severely limited by graft vs. host disease (GVHD) toxicity. AlloStim is designed to elicit the "mirror" of the GVT/GVHD effects in the host immune system. Rather than trying to separate these effects, we have proposed that the effects could remain associated and "mirrored" onto the host immune system creating linked host vs. tumor (HVT) and host vs. graft (HVG) effects. We hypothesized that allogeneic Th1 memory cells activated at time of infusion to produce type 1 cytokines and express CD40L would elicit HVT/HVG "mirror effects" in immunocompetent cancer patients.

Conditions

• Hematological Malignancy
• Leukemia
• Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	AlloStim	single intravenous infusion of 1 x 10\^9 AlloStim cells
BIOLOGICAL	AlloStim	Intravenous infusion of 1 x 10\^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10\^8 AlloStim on day 7
BIOLOGICAL	AlloStim	Intravenous infusion of 1 x 10\^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10\^8 AlloStim on day 7 and day 14
BIOLOGICAL	AlloStim	Intravenous infusion of 1 x 10\^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10\^8 AlloStim on day 7, day 14 and day 21

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2007-11-15
• Last updated: 2020-01-22

Locations

1 site across 1 country: Israel